Performance And On-site Evaluation Of HIV Self-testing With Urine

Objective: The target of HIV testing has not been reached yet.Under the current AIDS epidemic,HIV self-testing with urine as a new testing strategy will play an important role in AIDS prevention and control.The purpose of this study was to evaluate the performance of HIV urine self-testing kit and the field application effect of the HIV urine self-testing,to verify its ability to distinguish suspected HIV-infected people from non-infected people.Methods: From December 2017 to June 2018,a cluster random sampling method was adopted to continuously recruit HIV-infected,interfering,and general population aged 18 years and above in Beijing,Zhengzhou,Henan and Kunming,Yunnan.This study was divided into two parts: performance evaluation of assessment kit and a field evaluation: 1.Assessment kit(HIV urine self-testing kit)and reference kit(HIV blood-based testing kit)were used to detect HIV with urine and blood samples of subjects,and the evaluation indexes were sensitivity,specificity,Youden Index,likelihood ratio,predictive value,and Kappa coefficient;2.The subjects volunteered to participate in the field trial,including questionnaire survey,interpretation of a result model,self-testing at testing institutions and at home.The evaluation indexes were questionnaire scores,scores difference within different groups,questionnaire error rate,interpretation error rate of the result model,and Kappa coefficient.Results: A total of 1495 subjects were enrolled.1.By testing the samples of all subjects,the sensitivity of the assessment reagent is 99.44%,the specificity is 100.00%,the Youden’s index is 0.9944,the positive likelihood ratio is infinite,the negative likelihood ratio is 0.998,the positive predictive value is 100.00%,and the negative predictive value is 99.81%.In the consistency test between the assessment reagent and the reference reagent,Kappa coefficient was 0.998.2.The number of subjects for each project volunteered in the field trial was different,among which 1066 subjects filled in the questionnaire,and the scores of different groups were statistically significant(P<0.001),the error rate of question four,nine and ten were 15.29%,22.05% and 17.73% respectively;1064 subjects interpreted the result model.The error rate of weak positive and invalid result interpretation was the highest,which were 6.86% and 15.04% respectively.1078 subjects conducted selftesting in the testing institutions,and the Kappa coefficient was 0.995 in the consistency test with the laboratory test result.Only 102 subjects were re-tested at home,and the results were the same as in the test institutions.Conclusions: This multicenter study showed that HIV urine self-testing,as a new testing strategy,was accurate and reliable,and had a strong ability to distinguish suspected HIVinfected people from non-infected people.It provides a feasible,convenient,and safe tool for subjects to conduct personal self-testing under the condition of better concealment.This will make an important contribution to the achievement of the UNAIDS targets.